Abstract

Objective: The objective of the study was to develop and validate a rapid selective bioanalytical method for the simultaneous determination of metformin and canagliflozin in plasma by liquid chromatography-tandem mass spectrometer (LC-MS/MS) to facilitate bioequivalence study sample analysis. Stock solutions and spiking solutions were prepared accurately in methanol and 80% methanol in water, respectively.

Methods: Chromatography monitored using Analyst 1.6.2 software. Method was found selective, no matrix effect, reproducible and consistent recovery, accuracy, precision, and stable in aqueous as well as extracted/matrix samples. Method found linear over the range 10–2000 ng/ml for metformin and 30–6000 ng/ml for canagliflozin. The method is successfully applied to analyze samples collected in a bioequivalence study after administration of metformin/canagliflozin 1000/150 mg to 24 healthy male volunteers.

Conclusion: Rapid, sensitive method for the simultaneous estimation of metformin and canagliflozin in plasma by LC-MS/MS is successfully developed, validated and applied to analyze 960 unknown samples of a bioequivalence study. Incurred sample reanalysis was revealed great reproducibility.

Source Normalized Impact per Paper (SNIP):2017: 0.492SNIP measures contextual citation impact by weighting citations based on the total number of citations in a subject field.

Impact per Publication (IPP): 0.588

Impact per Publication (IPP):2016: 0.588The Impact per Publication measures the average number of citations received in a particular year by papers published in the journal during the three preceding years.

SCImago Journal Rank (SJR): 0.22

SCImago Journal Rank (SJR):2017: 0.22SJR is a prestige metric based on the idea that not all citations are the same. SJR uses a similar algorithm as the Google page rank; it provides a quantitative and a qualitative measure of the journal’s impact.

Cite Score: 0.49

Cite Score:2017: 0.49CiteScore metrics are a new standard to measure serial citation impact.